Arcturus Therape - ARCT STOCK NEWS

CSL (CSLLY) and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. The approval follows a positive CHMP opinion from December 12, 2024, and is valid across all EU member states and EEA countries.

KOSTAIVE, already marketed in Japan, demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on positive data from multiple studies, including an integrated phase 1/2/3 study and Phase 3 booster trials, which showed higher immunogenicity results versus a conventional mRNA COVID-19 vaccine comparator.

CSL and Arcturus Therapeutics (ARCT) have received European Commission marketing authorization for KOSTAIVE®, the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for individuals 18 and older. The approval follows a positive CHMP opinion from the European Medicines Agency on December 12, 2024.

KOSTAIVE demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on data from multiple studies, including an integrated phase 1/2/3 study showing efficacy and tolerability, and Phase 3 booster trials.

The vaccine is already marketed in Japan and will be valid across all EU member states and EEA countries. CSL is working to optimize KOSTAIVE's formulation to better serve healthcare professionals and patients in Europe.

Arcturus Therapeutics (Nasdaq: ARCT) has announced the appointment of Dr. Moncef Slaoui as Chair Designate. Dr. Slaoui, who has been serving on the Company's Board of Directors since June 2024, brings extensive experience in the pharmaceutical and biotechnology industry. The company, which focuses on commercial messenger RNA medicines for infectious disease vaccines and rare diseases affecting liver and respiratory systems, is entering what it describes as a transformative year with multiple key data readouts expected across its pipeline.

Meiji Seika Pharma has received approval to add domestic manufacturing sites in Japan for KOSTAIVE®, their self-amplifying mRNA COVID-19 vaccine. The approval enables integrated production within Japan, with ARCALIS's Minami-soma facilities and Meiji Seika Pharmatech added as manufacturing sites.

The technology transfer was managed by CSL Seqirus, the global licensor of KOSTAIVE®. The domestic production includes manufacturing of active pharmaceutical ingredients at ARCALIS's facilities and formulation at Meiji Seika Pharmatech, allowing for commercial distribution in Japan. This development involves Arcturus Therapeutics' LUNAR® lipid nanoparticle formulation processes and STARR® sa-mRNA drug substance manufacturing technologies.

Arcturus Therapeutics (ARCT) has initiated a Phase 1 study of ARCT-2304 (LUNAR-H5N1), a self-amplifying mRNA vaccine candidate for pandemic H5N1 influenza prevention. The trial, fully funded by BARDA, began in December 2024 and aims to enroll approximately 200 healthy adults across multiple U.S. sites.

The randomized placebo-controlled study will evaluate three dose levels and two vaccination schedules, focusing on safety and immune responses measured through various assays. The vaccine utilizes LUNAR® delivery and STARR® mRNA technologies, which have previously demonstrated robust immune responses at low doses and extended neutralizing antibody persistence compared to conventional mRNA vaccines.

LUNAR-H5N1 becomes the third STARR® mRNA vaccine to enter clinical trials, with interim Phase 1 data expected in H2 2025. The technology's safety profile has been established through previous trials involving over 20,000 participants.

Arcturus Therapeutics (ARCT) has initiated Phase 2 dosing for both its Cystic Fibrosis (CF) and Ornithine Transcarbamylase (OTC) deficiency therapeutic programs in December 2024. In the CF study (NCT06747858), participants will receive daily treatments of ARCT-032 over 28 days. For the OTC deficiency program, the first participant received 0.5 mg/kg of ARCT-810 in the United States, with participants scheduled to receive five intravenous infusions over two months.

The company previously completed a placebo-controlled European study for OTC deficiency (N = 8; 0.3 mg/kg) and expanded the Phase 2 clinical program of ARCT-810 into the US with an open-label multiple-dose study (NCT06488313). Interim data for both mRNA therapeutic programs is expected in the first half of 2025.

Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Joseph Payne, President & CEO, will deliver a presentation at the conference in San Francisco on Wednesday, January 15, 2025, at 9:45 a.m. Pacific Time. Investors and interested parties can access the presentation webcast and replay through the company's investor relations website at ir.arcturusrx.com/investor-calendar.

Arcturus Therapeutics (Nasdaq: ARCT), a commercial mRNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in three upcoming investor conferences in December 2024. The company will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 3 at 4:30 p.m. ET, attend Citi's 2024 Global Healthcare Conference on December 4, and join another fireside chat at the 7th Annual Evercore HealthCONx Conference on December 5 at 8:45 a.m. ET. Webcast links will be available on the company's website under the Investor Relations/Events section.

Arcturus Therapeutics (Nasdaq: ARCT), a commercial mRNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in the Jefferies London Healthcare Conference. The presentation is scheduled for Wednesday, November 20, 2024, at 9:30 am GMT in London. Interested parties can access both the live webcast and replay of the presentation through the Investor Relations/Events section on the company's website.